Gastric Cancer
Conditions
Keywords
metastatic gastric cancer, neurotoxicity, mFOLFOX6, monosialotetrahexosylganglioside Sodium Injection
Brief summary
For gastric patients of Karnofsky scores between 60-80 scores, mFolfox6 is an option for chemotherapy. Neutropenia and oxaliplatin-induced neurotoxicity are the most common adverse effects which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity. Monosialotetrahexosylganglioside is a component of membrane of nerve cells. Previous phase II clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity(OIN). But it did not certificated by phase III trial. A phase III trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside Sodium Injection for prevention OIN at gastric cancer.
Detailed description
it is a placebo controlled phase III trial. Investigators plan to enroll 240 patients with 1:1 to A arm and B arm
Interventions
it is extracted from pig's brain,shenjie is the brand name
OTHERplacebo
saline of the same appearance as monosialotetrahexosylganglioside Sodium
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients shall have normal organic function such as liver function, Cardiac function and renal function; 2. age \>18 years old; 3. diagnosis metastatic colorectal cancer with histology; 4. Did not received first-line chemotherapy 5. Karnofsky Performance scores should be 60,70,or80 6. should have target lesions or non-target lesions 7. For patients received oxaliplatin before, the residual neurotoxicity should less than grade 2 8. For diabetes without neuropathy, blood glucose before meal should less than 8mmol/L and HBA1C\<7.0% 9. Patients should be expected to live no shorter than 3 months
Exclusion criteria
1. patients who is receiving chemotherapy; 2. WBC\<4.0×109/L，ANC\<1.5×109/L,PLT\<100×109/L，Hb\<90g/L,TBIL\>1.5Limitation;BUN）\>1.5Limitation；Cr）\>1.5Limitation；ALT or AST\>2.5Limitation（without liver metastasis）；ALT or AST）\>5Limitation（with liver metastasis）; 3. heart dysfunction; 4. brain metastasis; 5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy; 6. patients who received Glutathione, acetylcysteine, calcium / magnesium, amifostine, carbamazepine, B vitamins, vitamin E within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity | From the first day of chemotherapy to 12 months after study or until one week before the patients receive second-line chemotherapy | acute neurotoxicity will be assessed the first day of oxaliplatin at every cycle given;accumulating neurotoxicity will be assessed every two weeks from the second day of first cycle until the patients out of the study. The accumulating neurotoxicity will be assessed every four weeks for 12 months or one week before second-line chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Eevery 6 weeks, up to 24 months | investigators assess the effect every six weeks and objective response is recorded as complete response,partial response or stable disease according to Recist 1.1 |
| Progress Free Survival | investigators assess the effect of chemotherapy every 6 weeks ,up to 24 months | From date of randomization until the date of first documented progression |
| overall Survival | From date of randomization until the date of death from any cause, assessed up to 100 months | the patients will be followed one month after progression ,then every 3 months,up to 100 months |
| quality of life | evaluate 1 week before chemotherapy and every 6 weeks of study. And evaluate within 4 weeks after the patients out of the study | investigators use sf-36 to evaluated the quality of life |
Countries
China
Contacts
Primary ContactYI Ba, MD PHD
Outcome results
None listed